Clinical Study Schedule of Activities
1.0.0 - trial-use

Clinical Study Schedule of Activities, published by HL7 International - Biomedical Research & Regulation Work Group. This is not an authorized publication; it is the continuous build for version 1.0.0). This version is based on the current content of https://github.com/HL7/Vulcan-schedule-ig/ and changes regularly. See the Directory of published versions

## : H2Q-MC-LZZT Research Study - JSON Representation

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    {
      "resourceType" : "ResearchStudy",
      "id" : "H2Q-MC-LZZT-ResearchStudy",
      "meta" : {
        "profile" : [
          "http://hl7.org/fhir/uv/vulcan-schedule/StructureDefinition/ResearchStudySoa"
        ]
      },
      "text" : {
        "status" : "generated",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ResearchStudy</b><a name=\"H2Q-MC-LZZT-ResearchStudy\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ResearchStudy &quot;H2Q-MC-LZZT-ResearchStudy&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ResearchStudySoa.html\">ResearchStudySoa</a></p></div><p><b>identifier</b>: id:\u00a0H2Q-MC-LZZT\u00a0(use:\u00a0USUAL), id:\u00a0NCTA12313212\u00a0(use:\u00a0OFFICIAL), id:\u00a060809</p><p><b>title</b>: Safety and Efficacy of the Xanomeline Transdermal Therapeutic System (TTS) in Patients with Mild to Moderate Alzheimer’s Disease</p><p><b>protocol</b>: <a href=\"PlanDefinition-H2Q-MC-LZZT-ProtocolDesign.html\">PlanDefinition/H2Q-MC-LZZT-ProtocolDesign</a></p><p><b>status</b>: completed</p><p><b>primaryPurposeType</b>: Treatment <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-research-study-prim-purp-type.html\">ResearchStudyPrimaryPurposeType</a>#treatment)</span></p><p><b>phase</b>: Phase 3 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-research-study-phase.html\">ResearchStudyPhase</a>#phase-3)</span></p><p><b>category</b>: Interventional Study <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (ncimeta.nci.nih.gov#C98388)</span>, Randomized Clinical Trial <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (ncimeta.nci.nih.gov#C15417)</span>, Double Blind Study <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (ncimeta.nci.nih.gov#C15228)</span>, Placebo Control <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (ncimeta.nci.nih.gov#C49648)</span>, Parallel Study <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (ncimeta.nci.nih.gov#C82639)</span></p><p><b>focus</b>: Xanomeline <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (ncimeta.nci.nih.gov#C152926)</span>, Transdermal Patch Dosage Form <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (ncimeta.nci.nih.gov#C149996)</span>, PUBMED#9109749 Effects of xanomeline, a selective muscarinic receptor agonist, on cognitive function and behavioral symptoms in Alzheimer disease <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>condition</b>: Alzheimer's Disease (Disorder) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"https://browser.ihtsdotools.org/\">SNOMED CT</a>#26929004)</span></p><p><b>contact</b>: Bob James, Ph.D.: ph: 555-555-5555(WORK)</p><h3>RelatedArtifacts</h3><table class=\"grid\"><tr><td>-</td><td><b>Type</b></td><td><b>Label</b></td><td><b>Display</b></td><td><b>Citation</b></td><td><b>Url</b></td></tr><tr><td>*</td><td>documentation</td><td>Arch Neurol.1997;54(4):465-473</td><td>Arch Neurol.1997;54(4):465-473</td><td>Bodick NC, Offen WW, Levey AI, et al. Effects of xanomeline, a selective muscarinic receptor agonist, on cognitive function and behavioral symptoms in Alzheimer disease. Arch Neurol. 1997;54(4):465-473. doi:10.1001/archneur.1997.00550160091022</td><td> </td></tr><tr><td>*</td><td>documentation</td><td>Protocol H2Q-MC-LZZT(c)</td><td> </td><td> </td><td><a href=\"https://clinicaltrials.gov/show/NCTA12313212/Lzzt_protocol_redacted.pdf\">https://clinicaltrials.gov/show/NCTA12313212/Lzzt_protocol_redacted.pdf</a></td></tr></table><p><b>keyword</b>: Selective M1 muscarinic agonists <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-MeSH.html\">Medical Subject Headings</a>#D018721)</span>, Alzheimer Disease <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-MeSH.html\">Medical Subject Headings</a>#D000544)</span>, Selective M1 muscarinic agonists <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-MeSH.html\">Medical Subject Headings</a>#D018721)</span></p><p><b>description</b>: ## Xanomeline (LY246708)\n### Protocol H2Q-MC-LZZT(c) \nSafety and Efficacy of the Xanomeline Transdermal Therapeutic System (TTS) in Patients with Mild to Moderate Alzheimer’s Disease</p><p><b>sponsor</b>: <a href=\"Organization-EliLillyAndCompany.html\">Organization/EliLillyAndCompany</a></p><p><b>principalInvestigator</b>: <a href=\"Practitioner-SamGetWell.html\">Practitioner/SamGetWell</a> &quot; HOME&quot;</p><p><b>reasonStopped</b>: Accrual Goal Met <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-research-study-reason-stopped.html\">ResearchStudyReasonStopped</a>#accrual-goal-met)</span></p><blockquote><p><b>arm</b></p><p><b>name</b>: Placebo</p><p><b>type</b>: C49648 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (ncimeta.nci.nih.gov#C49648)</span></p><p><b>description</b>: Placebo arm</p></blockquote><blockquote><p><b>arm</b></p><p><b>name</b>: Low-dose xanomeline arm</p><p><b>type</b>: C174266 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (ncimeta.nci.nih.gov#C174266)</span></p><p><b>description</b>: Low-dose xanomeline arm (50 cm2 TTS Formulation E, 54 mg xanomeline)</p></blockquote><blockquote><p><b>arm</b></p><p><b>name</b>: High-dose xanomeline arm</p><p><b>type</b>: C174266 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (ncimeta.nci.nih.gov#C174266)</span></p><p><b>description</b>: High-dose xanomeline arm (75 cm2 TTS Formulation E, 81 mg xanomeline)</p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: To determine if there is a statistically significant relationship (overall Type 1 error rate, α=.05) between the change in both ADAS-Cog and CIBIC scores, and drug dose (0, 50 cm2 [54 mg], and 75 cm2 [81 mg]).</p><p><b>type</b>: Primary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#primary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: To document the safety profile of the xanomeline TTS.</p><p><b>type</b>: Primary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#primary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: To assess the dose-dependent improvement in behavior. Improved scores on the Revised Neuropsychiatric Inventory (NPI-X) will indicate improvement in these areas.</p><p><b>type</b>: Secondary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#secondary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: To assess the dose-dependent improvements in activities of daily living. Improved scores on the Disability Assessment for Dementia (DAD) will indicate improvement in these areas.</p><p><b>type</b>: Secondary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#secondary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: To assess the dose-dependent improvements in an extended assessment of cognition that integrates attention/concentration tasks. The Alzheimer’s Disease Assessment Scale-14 item Cognitive Subscale, hereafter referred to as ADAS-Cog (14), will be used for this assessment.</p><p><b>type</b>: Secondary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#secondary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: To assess the treatment response as a function of Apo E genotype.</p><p><b>type</b>: Secondary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#secondary)</span></p></blockquote></div>"
      },
      "identifier" : [
        {
          "use" : "usual",
          "value" : "H2Q-MC-LZZT"
        },
        {
          "use" : "official",
          "system" : "https://clinicaltrials.gov/show/",
          "value" : "NCTA12313212"
        },
        {
          "value" : "60809"
        }
      ],
      "title" : "Safety and Efficacy of the Xanomeline Transdermal Therapeutic System (TTS) in Patients with Mild to Moderate Alzheimer’s Disease",
      "protocol" : [
        {
          "reference" : "PlanDefinition/H2Q-MC-LZZT-ProtocolDesign"
        }
      ],
      "status" : "completed",
      "primaryPurposeType" : {
        "coding" : [
          {
            "system" : "http://terminology.hl7.org/CodeSystem/research-study-prim-purp-type",
            "code" : "treatment"
          }
        ]
      },
      "phase" : {
        "coding" : [
          {
            "system" : "http://terminology.hl7.org/CodeSystem/research-study-phase",
            "code" : "phase-3"
          }
        ]
      },
      "category" : [
        {
          "coding" : [
            {
              "system" : "http://ncimeta.nci.nih.gov",
              "code" : "C98388",
              "display" : "Interventional Study"
            }
          ]
        },
        {
          "coding" : [
            {
              "system" : "http://ncimeta.nci.nih.gov",
              "code" : "C15417",
              "display" : "Randomized Clinical Trial"
            }
          ]
        },
        {
          "coding" : [
            {
              "system" : "http://ncimeta.nci.nih.gov",
              "code" : "C15228",
              "display" : "Double Blind Study"
            }
          ]
        },
        {
          "coding" : [
            {
              "system" : "http://ncimeta.nci.nih.gov",
              "code" : "C49648",
              "display" : "Placebo Control"
            }
          ]
        },
        {
          "coding" : [
            {
              "system" : "http://ncimeta.nci.nih.gov",
              "code" : "C82639",
              "display" : "Parallel Study"
            }
          ]
        }
      ],
      "focus" : [
        {
          "coding" : [
            {
              "system" : "http://ncimeta.nci.nih.gov",
              "code" : "C152926",
              "display" : "Xanomeline"
            }
          ]
        },
        {
          "coding" : [
            {
              "system" : "http://ncimeta.nci.nih.gov",
              "code" : "C149996",
              "display" : "Transdermal Patch Dosage Form"
            }
          ]
        },
        {
          "text" : "PUBMED#9109749 Effects of xanomeline, a selective muscarinic receptor agonist, on cognitive function and behavioral symptoms in Alzheimer disease"
        }
      ],
      "condition" : [
        {
          "coding" : [
            {
              "system" : "http://snomed.info/sct",
              "code" : "26929004",
              "display" : "Alzheimer's Disease (Disorder)"
            }
          ]
        }
      ],
      "contact" : [
        {
          "name" : "Bob James, Ph.D.",
          "telecom" : [
            {
              "system" : "phone",
              "value" : "555-555-5555",
              "use" : "work"
            }
          ]
        }
      ],
      "relatedArtifact" : [
        {
          "type" : "documentation",
          "label" : "Arch Neurol.1997;54(4):465-473",
          "display" : "Arch Neurol.1997;54(4):465-473",
          "citation" : "Bodick NC, Offen WW, Levey AI, et al. Effects of xanomeline, a selective muscarinic receptor agonist, on cognitive function and behavioral symptoms in Alzheimer disease. Arch Neurol. 1997;54(4):465-473. doi:10.1001/archneur.1997.00550160091022"
        },
        {
          "type" : "documentation",
          "label" : "Protocol H2Q-MC-LZZT(c)",
          "url" : "https://clinicaltrials.gov/show/NCTA12313212/Lzzt_protocol_redacted.pdf"
        }
      ],
      "keyword" : [
        {
          "coding" : [
            {
              "system" : "https://www.nlm.nih.gov/mesh",
              "code" : "D018721"
            }
          ],
          "text" : "Selective M1 muscarinic agonists"
        },
        {
          "coding" : [
            {
              "system" : "https://www.nlm.nih.gov/mesh",
              "code" : "D000544"
            }
          ],
          "text" : "Alzheimer Disease"
        },
        {
          "coding" : [
            {
              "system" : "https://www.nlm.nih.gov/mesh",
              "code" : "D018721"
            }
          ],
          "text" : "Selective M1 muscarinic agonists"
        }
      ],
      "description" : "## Xanomeline (LY246708)\n### Protocol H2Q-MC-LZZT(c) \nSafety and Efficacy of the Xanomeline Transdermal Therapeutic System (TTS) in Patients with Mild to Moderate Alzheimer’s Disease",
      "sponsor" : {
        "reference" : "Organization/EliLillyAndCompany"
      },
      "principalInvestigator" : {
        "reference" : "Practitioner/SamGetWell"
      },
      "reasonStopped" : {
        "coding" : [
          {
            "system" : "http://terminology.hl7.org/CodeSystem/research-study-reason-stopped",
            "code" : "accrual-goal-met"
          }
        ]
      },
      "arm" : [
        {
          "name" : "Placebo",
          "type" : {
            "coding" : [
              {
                "system" : "http://ncimeta.nci.nih.gov",
                "code" : "C49648"
              }
            ]
          },
          "description" : "Placebo arm"
        },
        {
          "name" : "Low-dose xanomeline arm",
          "type" : {
            "coding" : [
              {
                "system" : "http://ncimeta.nci.nih.gov",
                "code" : "C174266"
              }
            ]
          },
          "description" : "Low-dose xanomeline arm (50 cm2 TTS Formulation E, 54 mg xanomeline)"
        },
        {
          "name" : "High-dose xanomeline arm",
          "type" : {
            "coding" : [
              {
                "system" : "http://ncimeta.nci.nih.gov",
                "code" : "C174266"
              }
            ]
          },
          "description" : "High-dose xanomeline arm (75 cm2 TTS Formulation E, 81 mg xanomeline)"
        }
      ],
      "objective" : [
        {
          "name" : "To determine if there is a statistically significant relationship (overall Type 1 error rate, α=.05) between the change in both ADAS-Cog and CIBIC scores, and drug dose (0, 50 cm2 [54 mg], and 75 cm2 [81 mg]).",
          "type" : {
            "coding" : [
              {
                "system" : "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
                "code" : "primary"
              }
            ]
          }
        },
        {
          "name" : "To document the safety profile of the xanomeline TTS.",
          "type" : {
            "coding" : [
              {
                "system" : "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
                "code" : "primary"
              }
            ]
          }
        },
        {
          "name" : "To assess the dose-dependent improvement in behavior. Improved scores on the Revised Neuropsychiatric Inventory (NPI-X) will indicate improvement in these areas.",
          "type" : {
            "coding" : [
              {
                "system" : "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
                "code" : "secondary"
              }
            ]
          }
        },
        {
          "name" : "To assess the dose-dependent improvements in activities of daily living. Improved scores on the Disability Assessment for Dementia (DAD) will indicate improvement in these areas.",
          "type" : {
            "coding" : [
              {
                "system" : "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
                "code" : "secondary"
              }
            ]
          }
        },
        {
          "name" : "To assess the dose-dependent improvements in an extended assessment of cognition that integrates attention/concentration tasks. The Alzheimer’s Disease Assessment Scale-14 item Cognitive Subscale, hereafter referred to as ADAS-Cog (14), will be used for this assessment.",
          "type" : {
            "coding" : [
              {
                "system" : "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
                "code" : "secondary"
              }
            ]
          }
        },
        {
          "name" : "To assess the treatment response as a function of Apo E genotype.",
          "type" : {
            "coding" : [
              {
                "system" : "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
                "code" : "secondary"
              }
            ]
          }
        }
      ]
    }